CT Scan Sizing for Perceval Sutureless Valve

Summary

The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves . Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.

Eligibility

Inclusion Criteria:

1. Male and female subjects \> 18 years;
2. Subjects willing to sign and date an informed consent for treatment of personal data;
3. Subjects willing and able to comply with the follow up schedule of the protocol;
4. Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
5. Subjects with possibly associated need for coronary revascularization.
6. Subjects with Ejection Fraction ≥ 40%

Exclusion Criteria:

1. Male and female subjects ≤ 18 years;
2. Subjects with bicuspid aortic valve
3. Subjects with associated mitral valvulopathy or ascending aorta aneurysm
4. Subjects with pure aortic insufficiency
5. Subjects with Ejection Fraction \< 40%
6. Subjects with acute myocardial infarction \< 30 gg
7. Subjects with serum creatinine \> 2 mg/Dl

Conditions2

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